Back to resultsA Study on the Long Term Survivals in an Expand Access Program (EAP) of Iressa
Primary Purpose
Non-small Cell Lung Cancer
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
EGFR Mutation Test
Ki-67 protein expression
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring EAP, Long term survival (3 years), Gefitinib, efficacy
Eligibility Criteria
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures.
- Participated in the Iressa EAP in China.
- Diagnosed as NSCLC.
- Patients who started EAP at least 3 years before this study initiated and have not yet terminated from the EAP (active long-term survivors).
- Patients who consent to provide blood sample and available archival tumour tissue sample for EGFR gene testing (provision of tumour tissue sample is optional).
Exclusion Criteria:
- Patients who disagree to participate this study.
- Patients in whose medical objection was recorded to use the existing data from medical practice for scientific research.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
1
2
3
Arm Description
Long term survivors who has been used IRESSA for more than 3 years and are still on gefitinib treatment
Long term survivors who has been used IRESSA for more than 3 years but have already terminated from EAP
Fast-progressors who defined as no more than 1 follow-up visit after recruitment with the reason of discontinuation being
Outcomes
Primary Outcome Measures
Describe the quality of life of long-term survivors who are not terminated from the EAP
Secondary Outcome Measures
To describe the current tumour control status via RECIST
To collect the risk factors related to prognosis in addition to the information already collected from EAP (age, gender, histology, smoking history, previous history of anti-cancer treatment, disease stage before starting gefitinib treatment, etc.)
To describe the treatment compliance of gefitinib in these patients
To describe the current clinical status of long-term survivors in the EAP program by clinical
To compare the key clinical features (age group, gender, histology, smoking history, disease stage, treatment-naive or pre-treated, response to prior chemotherapy,) in fast-progressors versus long-term survivals.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01000740
Brief Title
A Study on the Long Term Survivals in an Expand Access Program (EAP) of Iressa
Official Title
An International Expanded Access Clinical Programme With ZD1839 (IRESSATM) for Patients With Advanced Non-small Cell Lung Cancer (NSCLC) China Amendment 1: A Study on the Long Term Survivals in an Expand Access Program (EAP) of Iressa
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective is to describe the quality of life of long-term survivors who are not terminated from the EAP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
EAP, Long term survival (3 years), Gefitinib, efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Long term survivors who has been used IRESSA for more than 3 years and are still on gefitinib treatment
Arm Title
2
Arm Type
No Intervention
Arm Description
Long term survivors who has been used IRESSA for more than 3 years but have already terminated from EAP
Arm Title
3
Arm Type
No Intervention
Arm Description
Fast-progressors who defined as no more than 1 follow-up visit after recruitment with the reason of discontinuation being
Intervention Type
Genetic
Intervention Name(s)
EGFR Mutation Test
Intervention Description
Explore the EGFR mutation status from both tumour tissue sample and the free DNA in the peripheral blood using appropriate method(s) which may include ARMS assay, ME-PCR coupled sequencing and regular sequencing.
Intervention Type
Genetic
Intervention Name(s)
Ki-67 protein expression
Intervention Description
Ki-67 protein expression in tissue will be analysed by IHC method.
Primary Outcome Measure Information:
Title
Describe the quality of life of long-term survivors who are not terminated from the EAP
Secondary Outcome Measure Information:
Title
To describe the current tumour control status via RECIST
Title
To collect the risk factors related to prognosis in addition to the information already collected from EAP (age, gender, histology, smoking history, previous history of anti-cancer treatment, disease stage before starting gefitinib treatment, etc.)
Title
To describe the treatment compliance of gefitinib in these patients
Title
To describe the current clinical status of long-term survivors in the EAP program by clinical
Title
To compare the key clinical features (age group, gender, histology, smoking history, disease stage, treatment-naive or pre-treated, response to prior chemotherapy,) in fast-progressors versus long-term survivals.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of informed consent prior to any study specific procedures.
Participated in the Iressa EAP in China.
Diagnosed as NSCLC.
Patients who started EAP at least 3 years before this study initiated and have not yet terminated from the EAP (active long-term survivors).
Patients who consent to provide blood sample and available archival tumour tissue sample for EGFR gene testing (provision of tumour tissue sample is optional).
Exclusion Criteria:
Patients who disagree to participate this study.
Patients in whose medical objection was recorded to use the existing data from medical practice for scientific research.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Atkin
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Louis Zhang
Organizational Affiliation
AstraZeneca
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Longyun Li
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Research Site
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Research Site
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Research Site
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Research Site
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
Research Site
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Research Site
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Research Site
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Research Site
City
Hangzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
22681919
Citation
Li L, Zhong W, Liao M, Chen L, Han B, Guan Z, Yu S, Liu X, Wu Y, Jiang G, Xu J, Chen J, Tao M, Luo R, Li W, Xu N, Zhao X, Wang M. [A study on the long-term non-small cell lung cancer survivors in the Expand Access Program of gefitinib in China]. Zhongguo Fei Ai Za Zhi. 2012 Jun;15(6):332-9. doi: 10.3779/j.issn.1009-3419.2012.06.03. Chinese.
Results Reference
derived
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A Study on the Long Term Survivals in an Expand Access Program (EAP) of Iressa
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